Avomeen
Analytical Services breaks the mold of a traditional CRO by bringing multidisciplinary
experts from a range of industries together into a large state-of-the-art
facility. This unique blend of talent allows the fast-growing laboratory to
break away from just routine projects and allows them to effectively solve even
the most complex problems that often times arise within the research and
development stages of a pharmaceutical product. Headquartered in Ann Arbor, MI,
the analytical testing laboratory has seen tremendous year-over-year growth due
to its clients’ appreciation to the customization they receive, reliability of results,
and exemplary customer service. Drug Development & Delivery recently caught
up with Shri Thanedar, PhD, CEO & Chief Chemist at Avomeen Analytical
Services to discuss what sets his company’s analytical laboratory apart from
other CROs that serve the pharmaceutical industry, some of the laboratories
non-routine service offerings, and how their unique approach has helped them to
maintain the incredible year-over-year growth of the company.

Q: What makes Avomeen’s pharmaceutical development program
unique?

A:
Many CROs only work on projects withina
limited scope in order to complete a highvolume
of routine tests with little to nocustomization
to the individual client beingserved
or the specific sample beinganalyzed.
The caliber of our staff and ourability
to solve both unusual and highlycomplex
problems sets Avomeen apart fromthese
types of laboratories. At Avomeen,more
than 70% of our scientists are PhDs orMasters
Level, which is a much higherpercentage
than you will find in companiesgeared
toward high-volume routine work.Our
model is geared toward customizingevery
project to meet the specific needs ofthe
client. Our clients like that we are able tocreate
definitive methods on complexproducts,
such as an API that is difficult tosolubilize
or if they have an active ingredientto
be analyzed that is not a small moleculebut
instead is something larger, such as what is found whentesting an oatmeal based product what sets
Avomeen’sanalytical laboratory apart
from other CRO’s that serve thepharmaceutical
industry, some of the laboratories non-routineservice
offerings, and how their unique approach has helpedthem to maintain the incredible year-over-year growth of thecompany.

Q: Avomeen has about 35 current employees, what is the appeal of
a laboratory your size?

A:
We are a smaller CRO, this helps us to be nimble and reactto our clients’ needs in a faster manner.
When a new projectcomes onboard’ we
put together a dedicated specialized teamof
scientists whose skillsets are tailored specifically to that typeof work. We appeal to smaller and mid-sized
companies as abetter choice than
going with a large CRO because they areprimarily
focused on multi-billion dollar pharma companies andoften do not treat smaller companies with the same level ofrespect or attention as their more profitable
clients; whereas forus, small to
mid-sized pharmaceutical companies are our sweetspot. That is who we service most often, and as we are not avolume-based company, we are able to provide
them a higherquality and more
reliable service.When you have a
molecule you are relying on for the future ofyour
company, you want someone to take care of it and treat itas important as you would yourself, that is
where is we comein. Conversely,
there are also many very small CROscomposed
of just a few people. These laboratories don’t havethe necessary sophistication, quality systems, or advancedstate-of-the-art analytical instrumentation
that we offer. So weare not among
the monstrous organizations that only look forlarge
billion-dollar clients, and we are also not one of thereally small 3 to 5 person mom-and-pop-type
laboratories.

Q: What does Avomeen offer when it comes to pharmaceutical
development?

A: We
provide preformulation and formulation development, acomplete range of CMC analytical testing services, methoddevelopment, validation, and transfer
services, clinical trialmanufacturing,
stability, degradation, extractables/leachablesanalysis,
and more. The focus of our testing is taking the APIand getting it into the clinic as fast as possible. We are alsounique in that we can assist pharmaceutical
developers andresearchers at any
stage of their development process. Whetherpreclinical,
clinical, or after market, we are able to support theclients’ individual needs and quickly jump into action.

Q: Do you offer any services or expertise that other CROs do
not?

A: Many
CROs have skilled pharmaceutical scientists, but mostlack multidisciplinary scientists. They lack the polymer,
material,and metallurgy experience
that our staff possesses. BecauseAvomeen
also services other commercial and industrialindustries,
we have a broad base of expertise that includesinorganic
chemists, organic chemists, chemical engineers,pharmaceutical
scientists, material scientists, polymer chemists,and more. Due to this, we are able to handle situations thatland outside of the traditional drug molecule
testing. Forexample, many
extractables/leachables studies are performedon
rubber stoppers and other items that are polymer based. So while
many CROs do not have multidisciplinary expertise, we have the polymer
specialists you will require in-house that work together with our pharmaceutical
scientist to create a better E&L study for a rubber stopper and other
unique items than a typical CRO could.

Q: In addition to your broad expertise, does Avomeen differ from
typical CROs in any other ways?

A: Absolutely,
one of the key differences is our size. As a midsizedlaboratory, we are neither too small nor too big. We arenot so large as to only appeal to companies
like Pfizer orMerck who often look
for laboratories with high volume andnarrow
focus. Instead, we can cater to companies that requirea customized approach from a laboratory that
offers a rangeof services, this
helps insure their drug product gets to marketas
quick as possible and at a lower cost.

​

Our
customer contact is another thing that sets us apart; fromthe initial project discussion through the
completion of yourproject, our
clients are in communication directly with one ofour technical directors and their dedicated team of chemists.One thing that our clients really appreciate
is that even our internal
business development team is composed of experienced PhD scientists; what this
means for them is they get an experienced scientist helping them right from the
start by offering advice and suggestions during a complementary initial consultation
that helps to insure the project quoted and taken on will solve exactly what they
are looking to complete. We have had a number of clients request a large
package of services but unknowingly not include an item in their request list that
would have left them with regulatory troubles and delaysfurther
on down the line had our staff not picked up on it. That’s the difference you
get when you work with our sales staff who are experienced chemists versus most
laboratories sales staff who are composed of individuals who aren’t as familiar
with the industry and its regulatory requirements.

Q: What type of facilities and instrumentation do you have?

A:
Avomeen has state-of-the-art facilities for our pharmaceuticaldevelopment services, and we are constantly
expanding on ourgrowing
capabilities. We have multiple ISO 7-Compliant cleanrooms of various sizes spanning 1200 square feet oflaboratory space. We have the equipment to
perform both wetand dry granulation
as well as tablet presses and capsulemanufacturing
capabilities in order to create and prepareclinical
trial supplies. A few highlights of our tablet and capsuleinstrumentation are shown in the table.

A: We
believe so; we have been a fast growing company, averaging 40% to 70% year-
over-year growth for the first 3 years of the company. In the next 3 years, we
expect to double our size once again. This impressive growth is due to how much
mid-sized pharmaceutical companies appreciate our service offerings and technical
expertise, with many of our clients coming back to us with additional larger
projects after a successful timely completion of their project the first timearound.
Our model as a customized full-service CRO has proven to work, and as we
continue to grow, so does our capacity to better serve the pharmaceutical
marketplace. No one will ever question why you decided to use Avomeen, but they
may question why you didn’t.